BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ

    MDR report key: 23890548 · Received December 24, 2025

    Report

    Report Number
    2015691-2025-10587
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    December 7, 2025
    Report Date
    February 11, 2026
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DYG
    UDI-DI
    00690103150438
    PMA / PMN Number
    K233983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PREMARKET SUBMISSION: K822723 MULTIPLE ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION AND TO SECURE THE RETURN OF THE DEVICE. HOWEVER THE CUSTOMER HAS NOT RESPONDED NOR SENT THE DEVICE BACK FOR EVALUATION. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. WITH THE PROVIDED LOT NUMBER, A DEVICE HISTORY RECORD INVESTIGATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING-RELATED PROCESSES. AN MDR WAS SUBMITTED AGAINST THE SECOND CATHETER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE DEVICE HISTORY RECORD INVESTIGATION IS COMPLETE AND THE REPORT ID FOR THE SECOND CATHETER IS AVAILABLE. THE INSTRUCTIONS FOR USE STATES PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: THIS CATHETER REQUIRES SPECIAL TECHNIQUES FOR INSERTION AND REMOVAL. ELECTRODE DISLODGEMENT MAY RESULT FROM PULLING THE CATHETER OUT THROUGH THE PERCUTANEOUS SHEATH. AVOID FORCEFUL WIPING OR STRETCHING OF THE CATHETER DURING TESTING AND CLEANING AS NOT TO BREAK THE ELECTRODE WIRE CIRCUITRY. SINCE PROPER FUNCTIONING OF THE PACING CATHETER DEPENDS ON THE ELECTRICAL CONTINUITY OF ITS ELECTRODES AND INTERNAL WIRES, CARE SHOULD BE EXERCISED WHEN HANDLING THE CATHETER. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THE PRODUCT PASSED WITHOUT NONCONFORMANCES.

    Additional Manufacturer Narrative · 0

    REPORT WITH FDA REPORT ID: 2015691-2025-10593 WAS SUBMITTED FOR THE SECOND SWAN GANZ CATHETER THAT WAS USED DURING THE CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING USE, TWO SWAN GANZ PACING CATHETERS WERE NOT EFFECTIVE. NO ALLEGATIONS OF PATIENT INJURIES. FURTHER INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311018 SWAN-GANZ CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES PR D97130F5 66285922 00690103150438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown